(a) Field
The subject matter disclosed generally relates to quantifying the balance error scoring system or “BESS” to assess concussion severity.
Human standing balance is an established indicator of concussion severity (Guskiewicz K M. 2011. Clin J. Sports Med. 30:89-102), and for this reason is incorporated into sports-related concussion evaluation and standard operating protocols in rehabilitation (Cavanaugh, J T Guskiewicz, K M; et al. 2005. Sports Med. 35(11):935-50). The problem of limited on-field access to special equipment and the moderate-to-low reliability of simple sideline tests present challenges to managing concussion. Assessment of concussion severity must be made quickly in order to provide the best treatment.
Human standing balance can be assessed by sophisticated means like optical three-dimensional motion tracking systems and force plates which provide precise measurements of the kinematics and kinetics of the human body during standing balance, but these are confined to research laboratories because of space, costs, and set up (Lafond, D; Duarte M. et al. 2004. J. Biomech. 37: 1421-6). Automated products such as the Swaymeter™, Berg Balance Scale, and Balance Error Scoring System (BESS) are portable and require minimal training, but have marginal validity, give unreliable scores, and are environment- and tester-dependent (Barlow, M; Shlabach D. et al. 2011. Int. J Sports Phys Ther. 6(3):287-95; Bell D R; Guskiewicz K M et al. 2011. Sports Health. 3(3):287-95; Onate J A; Beck B C; et al. 2007. J Athl Train. 42(4): 445-51; Valovich-Mclead T C; Perrin D H; et al. 2003. J. Athl. Train. 38:51-6). Studies have reported poor reliability both between different raters (ICC=0.74) and for one rater grading the same test twice (ICC=0.57 (Finoff J T; Peterson J J; et al. 2009. P M. R. 1(1):50-4)). This suggests that BESS scores must change by almost 50% before the difference can be attributed to changes in balance rather than rater judgment variability (Finoff J T, 2009).
As a result, there is no reliable method to perform accurate balance assessment on the sideline (Clark M A et al. 2011) or in a small medical facility.
(b) Related Prior Art
In Furman G R, Lin C-C, Bellanca J, et al. 2013. Am J Sports Med. 20 (10), BESS was found to be better than balance accelerometer measure (BAM). In Howell, David R et al., 3D analysis using a ten camera motion analysis system is disclosed. In King et al. 2014. Arc Phys Med 95, the use of an Opal™ inertial sensor fastened at lumbar 5 with an elastic belt is disclosed. The Opal includes 2 linear accelerometers (mediolateral and AP) to detect postural sway.
US patent publication No. 20130035613 discloses a mobile phone application to test balance. In Patterson, Jeremy A. et al. 2014. Int J Athletic Therapy & Training, a mobile “app” by SWAY Medical LLC was compared to traditional BESS.
PCT publication WO201400045 discloses use of a sensor mat to determine at least two characteristics of a subject's activity by using a combination of sensors for force and foot orientation/motion/position.
US Patent Publication No. 20130171596 discloses a neurological assessment apparatus with multiple contact points and using visuals to elicit responses.
US Patent Publication No. 20140100486 discloses a computerized method for analyzing balance and vestibule-ocular reflex data. This disclosure describes data processing but says little about data acquisition.
PCT Publication WO2013/038214 discloses a “smart” shoe insole for gait analysis. PCT Publication WO2014/100045 discloses foot sensors which are connected to hardware on or near the foot. PCT Publication WO2013/158095 discloses the use of an accelerometer to assess patient safety.
There remains a need for an objective BESS System (“oBESS”) that is portable, inexpensive, and consistent, for assessing the severity of concussion on the field or in emergency medical clinics.